Overview

VA106483 Dose Response Study in Elderly Males

Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
0
Participant gender:
Male
Summary
The main purpose of the study is to evaluate the way VA106483 enters and leaves the blood and tissues over time and how the drug acts on and in the body at various dose levels compared to placebo in the same volunteer.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Vantia Ltd
Criteria
Inclusion Criteria:

- Male, Age: 65 years and above

- Using adequate contraception

- Medical history without clinically significant pathologies; no evidence of serious
pathology or disease

- Physical examination parameters without signs of serious disease

- No clinically significant ECG and lab safety tests (sodium must be within normal
range)

- Willing and able to participate and provides written informed consent

Exclusion Criteria:

- Cardiac insufficiency; signs or symptoms suggestive of heart failure or requiring
treatment with diuretics

- Supine arterial blood pressure higher than 170/100 mmHg or less than 105/60 mm Hg

- Presence of poorly controlled endocrine disorders

- Renal insufficiency, active hepatic and/or biliary disease

- Hyponatraemia. Serum sodium level must be within normal limits

- Syndrome of inappropriate antidiuretic hormone (ADH) secretion

- Symptoms suggestive of psychogenic or habitual polydipsia or of diabetes insipidus

- Known hypersensitivity to the IP or any constituent of the IP

- Use of any non-prescription preparation within 72 hours prior to study entry, with the
exception of defined pain killers

- A history of alcohol abuse or drug addiction within the last 2 years

- Positive screen for HIV, hepatitis B or C

- Currently taking any diuretics or any concomitant medication known to be a cytochrome
3A4 inhibitor

- Other protocol defined eligibility criteria may apply.